A/0 AFT-800 series Electrolytes/TCO2 analyzer User Manual MEIZHOU CORNLEY© HI-TECH CO. ,LTD. Meizhou Cornley Hi-Tech Co.,Ltd Oxford Medico Europe Limited Nanshan Industrial Estate,Baigong 6-9 Trinity Street, 514765,Meixian, Guangdong Dublin 2, P.R.China D02 EY47 lreland. Preface Meizhou Cornley Hi-Tech Co., Ltd. is an enterprise specialized in R&D, manufacture, marketing and service for clinical IVD instrument and life science instrument. The AFT-800D electrolyte analyzer is designed for accurate and + + + - 2+ rapid tests on ion concentration of Li , K , Na , Cl , Ca (the standard calcium ion modified pH value), pH value and total carbon dioxide content in serum samples. It uses ion selective electrode technique (ISE) and the pressure sensor to realize every test. Controlled by a microprocessor and equipped with the hierarchical menu software structure, the analyzer is simple and more convenient for users to operate. The Electrolyte analyzers of Meizhou Cornley Hi-Tech Co., Ltd. inherit all advantages of similar domestic and foreign products and improve in the structure, circuit, software and operating system with colorful touch screen. They are essential assistance for every laboratory as they are able to be a real sense from three to six parameters with high performance. The operation of every analyzer can be done in a simple hierarchical menu. The specification of the content is about the detailed installation and operation of electrolyte analyzer. AFT-800D electrolyte analyzer combines the advantages of our original analyze to test lithium, sodium, potassium chlorine, calcium concentration, pH value in one sample with the direct test on total carbon dioxide to improve the efficiency. At the same time, users can choose an optional automatic sampler according to the actual needs. Automatic sampling can improve the speed of analysis while the manual sampling is still available. + + + 2+ - In addition, please install the electrodes of AFT-800D in order: Li , K , Na , Ca , Cl , pH, Ref according to this manual. If you have any questions, please contact our customer service department. Meizhou Cornley Hi-Tech Co., Ltd. adopted independent packs of calibration solutions. The user can handle waste more conveniently. The analyzer increases data storage function for 10000 sample test record, 100 quality control records every QC level. Through three levels quality control test and input target value, the analyzer can be automatically calculate the slope and the deviation as well as the use of median verification slope and mean deviation. The aim of Meizhou Cornley Hi-Tech Co., Ltd.is to provide more advanced and better medical devices for the user. Notice: Without the written consent of the Meizhou Cornley Hi-Tech Co., Ltd., any individual or organization shall not reproduce, modify or translate this manual. Meizhou Cornley Hi-Tech Co., Ltd. reserves to change, modify, update or delete any part of this manual without prior notice. Cornley has the final right to interpret this manual. Meizhou Cornley Hi-Tech Co., Ltd. Contents CHAPTER 1 ABSTRACT .......................................................................................................... 1 1.1 APPLICABLE RANGE --------------------------------------------------------------------------------------------- 1 1.2 MODELS--------------------------------------------------------------------------------------------------------- 1 1.3 FEATURES-------------------------------------------------------------------------------------------------------- 1 1.4 STRUCTURE ----------------------------------------------------------------------------------------------------- 2 1.4.1 Appearance ............................................................................................................................... 2 1.4.2 Sensor System ........................................................................................................................... 4 1.4.3 Barcode Scanner ...................................................................................................................... 5 1.4.4 Reagents .................................................................................................................................... 5 1.5 WORKING ENVIRONMENT ----------------------------------------------------------------------------------- 6 CHAPTER 2 OPERATION CAUTIONS ................................................................................... 7 2.1 PRECAUTIONS ------------------------------------------------------------------------------------------------- 7 2.2 L ABELS -------------------------------------------------------------------------------------------------------- 8 2.3 SAMPLE COLLECTION AND STORAGE ----------------------------------------------------------------------- 11 2.4 FACTORS THAT MAY AFFECT THE ELECTRODE--------------------------------------------------------------- 12 2.4.1 Ionized calcium(iCa2+)and total calcium(tCa2+)................................................................ 12 2.4.2 Some factors that may affect the electrode..................................................................... 14 CHAPTER 3 WORKING PRINCIPLE ....................................................................................... 16 3.1 FLOW PATH---------------------------------------------------------------------------------------------------- 16 3.2 MEASURING PRINCIPLE--------------------------------------------------------------------------------------- 16 3.2.1 Reference Electrode ............................................................................................................... 17 3.2.2 pH Electrode............................................................................................................................ 17 3.2.3 ISE.............................................................................................................................................. 18 CHAPTER 4 TECHNICAL FEATURE ........................................................................................ 19 4.1PARAMETER---------------------------------------------------------------------------------------------------- 19 4.1.1 Measured Parameter ............................................................................................................ 19 4.1.2 Calculated Parameter............................................................................................................ 19 4.1.3 The normal ISE concentration range of Serum ................................................................ 19 4.1.4 Testing range........................................................................................................................... 20 4.1.5 Electrode Parameters............................................................................................................ 20 4.2 SAMPLE TYPE-------------------------------------------------------------------------------------------------- 20 4.3 TEST SPEED --------------------------------------------------------------------------------------------------- 20 4.4 MINIMUM SAMPLE VOLUME --------------------------------------------------------------------------------- 20 4.5 OUTPUT ------------------------------------------------------------------------------------------------------- 20 4.6 DIMENSION AND WEIGHT ------------------------------------------------------------------------------------ 21 4.7 FUSE ----------------------------------------------------------------------------------------------------------- 21 4.8 MEMORY------------------------------------------------------------------------------------------------------ 21 4.9 DISPLAY ------------------------------------------------------------------------------------------------------- 21 4.10 COMMUNICATION AGREEMENT --------------------------------------------------------------------------- 21 4.11 PRINTER ----------------------------------------------------------------------------------------------------- 21 CHAPTER 5 INSTALLATION .................................................................................................. 22 5.1 UNPACKING --------------------------------------------------------------------------------------------------- 22 5.2 INSTALLATION OF ACCESSORIES ------------------------------------------------------------------------------ 23 5.3 INSTALLATION OF ELECTRODES ------------------------------------------------------------------------------- 23 5.4 INSTALLATION OF PUMP TUBE---------------------------------------------------------------------------------27 5.5 INSTALLATION OF PRINTING PAPER ----------------------------------------------------------------------------27 5.6 INSTALLATION OF REAGENTS --------------------------------------------------------------------------------- 28 5.6.1 Installation of calibration solution...................................................................................... 28 5.6.2 Installation of TCO2 Reaction Solution ............................................................................... 29 5.7 INSTALLATION OF AUTOSAMPLER ---------------------------------------------------------------------------- 29 CHAPTER 6 MAIN MENU ................................................................................................. 32 6.1 POWER ON---------------------------------------------------------------------------------------------------- 32 6.2 SELF TEST ----------------------------------------------------------------------------------------------------- 32 6.3 MAIN MENU ------------------------------------------------------------------------------------------------- 32 6.4 TEST MENU--------------------------------------------------------------------------------------------------- 33 6.4.1 Place the Probe Cleanser at 25 cup .................................................................................... 33 6.4.2 Serum test ................................................................................................................................ 33 6.4.3 Emergency test ....................................................................................................................... 34 6.5 QC ------------------------------------------------------------------------------------------------------------ 34 6.6.1 QC Plot ...................................................................................................................................... 34 6.6.2 QC Test ...................................................................................................................................... 36 6.6 MAINTENANCE MENU ----------------------------------------------------------------------------------------37 6.6.1 ISE Deproteinization .............................................................................................................. 37 6.6.2 Flush .......................................................................................................................................... 38 6.6.3 Deep cleaning ......................................................................................................................... 38 6.6.3 ISE Cleaning ............................................................................................................................. 38 6.6.5 Na&pH conditioning .............................................................................................................. 38 6.6.6 Serum soak .............................................................................................................................. 39 6.6.7 One_ Key_Maintenance........................................................................................................ 39 6.6.8 TCO2 Deproteinization .......................................................................................................... 40 6.6.9 All Cleaning.............................................................................................................................. 40 6.7 SYSTEM SETUP------------------------------------------------------------------------------------------------ 40 6.7.1 Reference Range Configuration .......................................................................................... 41 6.7.2 Printer Setup ........................................................................................................................... 41 6.7.3 Unit Configuration ................................................................................................................. 41 6.7.4 Screen Configuration ............................................................................................................. 42 6.7.5 Testing Parameter .................................................................................................................. 42 6.7.6 Maintenance Setup ............................................................................................................... 42 6.7.7 Date&Time Configuration .................................................................................................... 43 6.7.8 QC Control Configuration ..................................................................................................... 43 6.7.9 Correlation Coefficient Configuration................................................................................ 44 6.7.10 Calibration Intervals Configuration.................................................................................. 44 6.7.11 Sampling Mode .................................................................................................................... 45 6.7.12 Sample Volume Configuration .......................................................................................... 45 6.7.13 Resistance Setup .................................................................................................................. 45 6.7.14 Data Transfer Mode ............................................................................................................ 45 6.7.15 Operation Mode................................................................................................................... 46 6.7.16 Other ...................................................................................................................................... 46 6.8 DATA MANAGER ---------------------------------------------------------------------------------------------- 46 6.8.1 Test Result .................................................................................................................................47 6.8.2 ISE Calibration Results............................................................................................................47 6.8.3 TCO2 Calibration Results ....................................................................................................... 48 6.8.4 Test Results Transmission ..................................................................................................... 48 6.9 SERVICE ------------------------------------------------------------------------------------------------------- 48 6.9.1 ShutDown ................................................................................................................................ 48 6.9.2 Version...................................................................................................................................... 49 6.9.3 Help ........................................................................................................................................... 49 6.9.4 Tools .......................................................................................................................................... 49 6.9.5 Self Test .................................................................................................................................... 49 6.9.6 Sample Needle Adjust ........................................................................................................... 50 6.9.7 Sample Tray Adjust ................................................................................................................ 50 6.9.8 Multiplexer Check .................................................................................................................. 50 6.9.9 Cal Pack Used .......................................................................................................................... 51 6.9.10 TCO2 Clog Check ................................................................................................................... 51 6.10 CONSUMABLES MANAGEMENT ---------------------------------------------------------------------------- 51 CHAPTER 7 CALIBRATION ................................................................................................... 53 7.1 GENERAL INFORMATION -------------------------------------------------------------------------------------- 53 7.2 ONE POINT CALIBRATION ------------------------------------------------------------------------------------- 53 7.3 TWO POINT CALIBRATION------------------------------------------------------------------------------------- 54 7.4 LI_K VALUE ADJUSTMENT------------------------------------------------------------------------------------ 55 7.5 TCO2 CALIBRATION------------------------------------------------------------------------------------------- 55 7.6 ISE+TCO2 CALIBRATION ------------------------------------------------------------------------------------- 56 7.7 CALIBRATION INTERVALS ------------------------------------------------------------------------------------- 56 7.8 CALIBRATION RESULTS ---------------------------------------------------------------------------------------- 56 CHAPTER 8 PATIENT SAMPLE ANALYSIS .............................................................................. 58 8.1 SAMPLE COLLECTION ----------------------------------------------------------------------------------------- 58 8.2 STEPS OF SAMPLE ANALYSIS --------------------------------------------------------------------------------- 58 8.3 TEST RESULT -------------------------------------------------------------------------------------------------- 59 CHAPTER 9 TROUBLE SHOOTING.........................................................................................60 9.1 NORMAL TROUBLES AND SOLUTIONS ----------------------------------------------------------------------- 60 9.2 ELECTRODE --------------------------------------------------------------------------------------------------- 60 9.2.1 Drifting ..................................................................................................................................... 60 9.2.2 Unstable ................................................................................................................................... 60 9.2.3 Slow reaction and low slope ................................................................................................ 61 9.3 A SIMPLE METHOD TO CHECK RESPONDENT CIRCUIT CHANNEL OF EACH ELECTRODE ---------------------- 61 9.4 ONLY ONE UNSTABLE ELECTRODE ---------------------------------------------------------------------------- 61 9.5 TWO OR MORE UNSTABLE ELECTRODES --------------------------------------------------------------------- 61 9.6 LONGER BALANCE TIME ON LI+、K+、CL-、CA2+ ELECTRODES----------------------------------------- 61 + 9.7 LONGER BALANCE TIME ON NA 、PH ---------------------------------------------------------------------- 61 9.8 PROBLEMS ON FLOW PATH -----------------------------------------------------------------------------------62 9.9 SLOPE OUT OF RANGE -----------------------------------------------------------------------------------------62 9.10 PROBLEMS ON REPEATABILITY-------------------------------------------------------------------------------62 9.11 PROBLEMS ON ACCURACY-----------------------------------------------------------------------------------62 9.12 PROBLEMS ON QC-------------------------------------------------------------------------------------------62 9.13 PROBLEMS ON FUSE ---------------------------------------------------------------------------------------- 63 9.14 NO FLUSH OR FLOW SLOWLY ------------------------------------------------------------------------------- 63 9.15 NO CAL A OR CAL B ---------------------------------------------------------------------------------------- 63 9.16 NO SAMPLE WHEN SAMPLING------------------------------------------------------------------------------ 63 9.17 PROBLEMS ON PUMP TUBES ------------------------------------------------------------------------------- 64 9.18 LOOSE CONNECTOR----------------------------------------------------------------------------------------- 64 CHAPTER 10 MAINTENANCE .............................................................................................. 65 10.1 DAILY MAINTENANCE --------------------------------------------------------------------------------------- 65 10.2 WEEKLY MAINTENANCE ------------------------------------------------------------------------------------ 65 10.3 MONTHLY MAINTENANCE ---------------------------------------------------------------------------------- 66 10.4 YEARLY MAINTENANCE ------------------------------------------------------------------------------------- 66 10.5 AS NECESSARY ---------------------------------------------------------------------------------------------- 66 10.6 SHELF LIFE --------------------------------------------------------------------------------------------------- 66 10.7 TRANSPORTATION AND STORAGE----------------------------------------------------------------------------67 APPENDIX A SYMOBOLS.................................................................................................. 68 APPENDIX B BARCODE SCANNER INITIALIZATION ............................................................70 Chapter 1 Abstract This chapter introduces the scope of application, model characteristics and the composition of the structure about AFT-800D series electrolyte analyzer, 1.1 Applicable Range 1.1.1 This manual applies to AFT-800D series electrolyte analyzer (hereinafter referred to as the analyzer). 1.1.2 This analyzer for the medical tests on contents of K+, Na+, Cl-, Ca2+, Li+, pH, TCO2 in serum samples. 1.1.3 This analyzer should be operated by trained technicians, nurses, doctors in the laboratory, bedside monitoring or designated guardian. 1.2 Models Depending on different configuration, the analyzer has many types. This manual is composed according to the most completed configuration model (AFT-800D). The manual also applies to other models listed below. The differences between different models are: 1) The operation menu and display, such as the menu of calibration, testing and setup to display only some certain parameters. 2) The calculated parameters are different. Model AFT-800A AFT-800B AFT-800D AFT-800E AFT-800F AFT-800G AFT-800H Parameters K , Na , Cl-, TCO2 K+, Na+, Cl-, Ca2+, pH, TCO2 K+, Na+, Cl-, Ca2+, Li+, pH, TCO2 K+, Na+, ClK+, Na+, Cl-, Li+ K+, Na+, Cl-, Ca2+, pH K+, Na+, Cl-, Ca2+, Li+, pH + + 1.3 Features ※ Support color TFT touch screen, and brightness adjustable. ※ Optional auto sampler ※ Support original blood sample tube ※ Built-in thermal printer, serial port ※ Reagent and waste in one pack Page 1 Note AFT-800D series have the same appearance but different parameters. ※ Storage and search function on quality control, calibration and test results (store 10000 test results, 100 quality control results per level, 31 days quality control graph and 7 days calibration records) ※ Clot alarm and bubble alarm function, automatic and manual clot-removal function ※ Support LIS, HL7 ※ Automatic and manual calibration, cleaning, quality control and self check functions ※ Printing on sample analysis report and sample analysis chart ※ Printing on test report ※ Barcode scanning function to support consumables scan ※ Automatically identify the expiry date of consumables ※ Online software upgrade ※ Reagent consumption calculation function ※ To review and print test result according to the sample number or test time ※ Support print of calibration and quality control data ※ Support export of test data ※ Support multitasking operating and sample edition on patient information ※ Automatic cleaning for sampling needle ※ Support online graphic guide and online assistance 1.4 Structure The system includes main analyzer (Display, measuring chamber, peristaltic pump, multiplexer, flow path, printer), autosampler, barcode scanner and reagent pack. 1.4.1 Appearance Front Page 2 Part Function Display Interface between operator and analyzer Measuring chamber The place to do test Peristaltic Pump Sample aspiration and waste drain Calibration solution The place for both reagent and waste Manual sampling Aspiration of samples and reagents Autosampler For automatic sampling multiplexer Control the flow of liquid TCO2 reaction cell The place for sample and reaction solution to generate total dissolved CO2 Printer Print out test results and messages Back Part Barcode scanner interface Nameplate Barcode scanner RS232 interface(communication) Autosampler interface Function Connect analyzer and barcode scanner Describe the basic information and configuration of the analyzer Slot for scanner, read barcode of consumable Data transmission Connect analyzer and autosampler Page 3 Side Part Function For the analyzer to boot into standby mode Power inlet Note: when the analyzer is connected with an external power supply, analyzer is in standby mode. If the analyzer is not connected with any external power supply, the analyzer is in shutdown mode. Power switch Turn on or off the power Autosampler(Optional) 1.4.2 Sensor System This sensor system of this analyzer integrates modern technique of microelectrode. It can be used for the measurements of Li electrode(Li+) K electrode (K+) Na electrode (Na+) Ca electrode (Ca2+) Cl electrode (Cl-) Page 4 pH electrode (pH) Reference electrode(Ref) 1.4.3 Barcode Scanner The barcode systems of reagent pack, electrode and other consumables contain necessary information such as lot number and the validity period. The scanner is for barcode scanning to control the use of consumables. To scan the data of reagents(type, lot number, validity period) To scan the data of electrodes(type, lot number, validity period) To scan the data of pump tubes(type, lot number, validity period) To scan the data of sampling probe interfaces(type, lot number, validity period) Light Source Reading Mode Symbologies Resolution Scanning speed Interface Dimension Weight Working temperature Storage temperature Humidity Instruction 620 nm visible red light diode CCD Code128, EAN-13, EAN-8, Code 39, UPC-A, UPC-E, Codabar, Interleaved 2 of 5, ISBN, Code 93, UCC/EAN-128, GS1 Databar, etc. ≥4 mil 300 scans per second RS232 Length * width * height: 156mm×95mm×71mm 105g 0℃-50℃ -40℃-60℃ Relative humidity 0-95% (no condensation) 1.4.4 Reagents Calibration of the analyzer system is performed by the solution in the reagent pack. There is standard solution with accurate concentration in the pack. It is placed in the vacuum packaging. At the same time, waste will be collected in the bag automatically after calibration Page 5 and test. As standard calibration solution and waste are sealed in the pack, it can effectively avoid the pollution of the environment. The standard calibration solutions are used to calibrate Li+, K+, Na+, Ca2+, Cl- electrodes. After reagent is used out, the pack may contain biochemical dirt. The user is asked to avoid the contact with waste import. The pack should be handled in accordance with relevant provisions of biochemical sewage. One standard reagents pack includes: Type Calibration solution TCO2 reaction solution 1.5 Specification Cal A /Cal B Cleaning solution TCO2 standard solution 100ml/bottle Function To calibrate Li+,K+,Na+,Cl-,Ca2+,pH electrodes To Cleaning for the Flow path Storage Storage Temperature: 5-25℃. To calibrate TCO2 To generate CO2 with the sample No refrigeration Working Environment Temperature:10℃~40℃; Humidity:≤80%; Air pressure:86kPa~106kPa; Power Supply:100V-240V~,50Hz/60Hz; Working power:300VA; Desk Dimension: Length * Width ≥ (1.5*0.6) m2 Away from strong electromagnetic interference source and direct sunlight The analyzer after packing should be stored in an ambient temperature of -20℃~+55℃ and relative humidity of not more than 80%. It must be placed in a ventilated room without any corrosive gas. For long-term storage, the analyzer requires a power on and dehumidification for at least one hour once a month. Page 6 Chapter 2 Operation Cautions 2.1 ● Precautions No reagent of flame photometer or biochemistry analyzer can be used on this analyzer as such reagent may damage ion selective electrodes. ● Only the original reagent of Cornley can be used. ● Only the trained professional can operate the analyzer. ● Never use mildew or precipitated sample. Such sample should be abandoned immediately as it will affect the test result negatively. ● Never open the cover of measuring chamber when doing a test. ● Please protect the unique serial number on every electrode. There will be no after-sales guarantee for any electrode without such serial number. ● Please perform routine maintenance for the analyzer according to this manual. ● The analyzer needs stable voltage and good grounding. ● The serum must be separated well. The sample should be tested within 1 hour after collection. The TCO2 reaction cell for the sample must be cleaned by distilled water and dried. ● The adjustment on "slope" and "deviation" parameter must be done very carefully. Only the extremely fresh serum can be used for those adjustments. Please do not adjust the slope or deviation frequently. Generally, a micro adjustment will be OK enough. ● Please remain the analyzer power-on to guarantee the normal working of electrodes and test accuracy. ● Please avoid direct sunlight or other strong light on multiplexer ● Pressure sensor is a maintenance-free component. The replacement of this sensor can only be done by a professional appointed by Cornley(applicable for the models with TCO2 parameter)。 ● If the power of the analyzer is off for more than 24 hours, the left calibrator in the Flow path may be crystallized. This will ruin the future two-point calibrations on the analyzer. ● The protection of the analyzer may be damaged if the analyzer is not operated according to this manual. ● The handling of waste has to be done according to local standard and the guidance from the local distributor. Page 7 ● This analyzer is a precision instrument. After transportation, it needs to run at least 48 hours to return reliable. ● If the analyzer has any damage as the user does not supply stable power according to this manual, Cornley will not be responsible for the loss. 2.2 Labels For safe and effective operation of the analyzer, this manual lists several warning information. This part is very important. Please read carefully before the operation. Symbol Definition To remind the user to abide by the instructions. Otherwise there will be the risk of biological contamination. Biological contamination To remind the user to use of equipment safely and effectively. Alert To illustrate the procedure of important information or other information which need to remind to the users. Caution All risk warnings of this manual are listed as follows: Biological contamination: The collecting samples must follow the Sampling basic rules of prevention as all blood samples are potentially infectious. In order to reduce the possible risk, the collector must master the correct treatment of blood collection to wear gloves and take the necessary protective measures. Environment Pollution Biological contamination: Please always remember environment protection when you handle biological waste or its container. Biological contamination: The will be waste after the usage of every Reagents reagent pack. Please never touch the waste interface. Handle the splashed liquid with flush solution carefully. For the used packs of calibration solutions, please handle them according to local laws about biological waste. Biological contamination: Please switch off the analyzer and Analyzer disconnect the power supply when cleaning the analyzer. Gloves are also advised for this cleaning. Page 8 Alert: Never clean the sample probe with wet cloth or anything similar. Restrictions operation in Alert: Before being applied to clinical diagnosis, all test results of the analyzer need to be checked by the doctor according to the clinical status of the patient. Alert: All reagents have to be removed before shut-down of the analyzer. Storage Alert: For long term storage of the analyzer, the power supply must be shut down. Necessary shut-down procedures have to be followed also. Alert: Please observe the sample status in the measuring chamber to guarantee the integrity of the sample. Maintenance Alert: Please perform de-protein and conditioning for the electrodes regularly. Alert: Please install the tube correctly on the pump wheel to Pump Tube guarantee the normal rolling of the wheel. Alert: Never use any QC with Fluorine carbon compounds QC Biological contamination: When flushing any part of this analyzer, please be careful for the liquid outlet from the Flow path. Alert: Before being applied to clinical diagnosis, all test results of the Troubleshooting analyzer need to be checked by the doctor according to the clinical status of the patient. Caution: In order to guarantee a good EMC, please use protected cable at communication port. Caution: please contact the local distributor whenever necessary. Safety In order to use this analyzer safely, please read the content below carefully. There will be danger for the analyzer or the operator if the operation does not apply such safety instructions. Alert: If the user does not follow this manual, the safety protection system of this analyzer may fail. Page 9 Electric shock prevention\ To prevent electric shock, please notice that: Alert: Never open the back board of the analyzer when the power is on. Never put any reagent or sample on the analyzer. If any reagent or sample is splashed into the analyzer, please shut down the power immediately and contact the local distributor or Cornley for professional advice. Moving Parts To prevent the injury by the moving part of the analyzer, please notice that: Alert: Please do not touch or put your hand inside the range of moving part when the analyzer is working. Laser Radioactivity To prevent the injury by Laser light source of the barcode scanner, please notice that: Alert: Please do not look at the laser light source directly. It is harmful for the eyes. Blood Pollution To prevent the blood pollution for the operator, please notice that: Alert: Please never touch blood sample, interface of reagent pack, QC, calibrator and reaction solution. Please do wear gloves and necessary uniform to prevent possible pollution. Spectacles are also required if necessary. If any sample is splashed on the skin, please handle with care and consult a doctor. Chemical Danger To prevent chemical danger, please notice that: Alert: Some reagents and chemical flush solution are harmful for skin. If any of such liquid is splashed into eyes by accident, please wash with plenty of clean waters immediately and see a doctor without delay. Waste To prevent waste pollution, please notice that: Biological risk: some contents of QC, calibrator, flush and waste are dangerous. Please handle them according to relevant local laws. Please do wear gloves and necessary uniform to when handling waste. Spectacles are also required if necessary. Used analyzer To handle used analyzer safely. Alert: some materias of the used analyzer may cause pollution. Please handle them according to relevant local laws about waste products. Page 10 2.3 Sample collection and storage 2.3.1 Blood samples must be sent to the laboratory immediately after collection, especially when the environment temperature is over 22℃. 2.3.2 The tubes for blood samples must be sealed and placed vertically with mouth upwards. This is to reduce the coagulation completely by possible vibrations and to prevent contamination, evaporation and splashing, etc. 2.3.3 Blood samples can be collected according to the conventional method. The collected blood samples shall be handled gently to prevent hemolysis by possible vibrations. 2.3.4 The collected blood samples should be processed as early as possible. Generally, the isolation of serum from the samples must be done within two hours since collection. 2.3.5 The delivery of collected blood samples must be done with great cautious. The professional requests on packaging, temperature sample and processing methods must be strictly followed to ensure the stability of components. Sample tubes must be sealed and placed upward vertical during transportation. 2.3.6 The collected samples must be fully agglutinated. The samples with anticoagulant can be centrifuged immediately after collection. The samples with coagulant must be centrifuged within 5~15 minutes after collection. The samples with anticoagulant cannot be centrifuged if for tests on Lithium, Zinc and Protoporphyrin. 2.3.7 Blood samples before centrifugation should be agglutinated naturally. Please never use stick or anything similar to separate blood clots. For normal room temperature (22~25℃), the samples can be completely agglutinated after 30~60 minutes of collection. Frozen blood samples will be agglutinated slowly. They may need some coagulants to accelerate agglutination (gently reverse and mix 5~10 times to ensure the functions of coagulants). 2.3.8 It is better to complete sample centrifugation in one time. If a second centrifugation is needed, it should be done in a very short time after the previous one. But the samples with separated substances cannot be centrifuged again. 2.3.9 The storage of serum in 22~25℃cannot be over 8 hours. 2.3.10 If the centrifugation cannot be completed within 8 hours after collection, the serum should be kept in the environment of 2℃~8℃. 2.3.11 If centrifugation cannot be completed within 48 hours after collection, or the serum samples should be stored for 48 hours, the samples should be stored in -20℃. Page 11 2.3.12 For anticoagulants, the ones with heparin lithium shall not be applied when the tests include parameters about lithium. By the same means, the anticoagulants with heparin sodium shall not be applied when the tests include parameters about sodium. Otherwise the results of relevant parameters will be abnormal. 2.3.13 The serum samples cannot be frozen and thawed repeatedly. They can only be frozen and thawed once. Such samples cannot be stored in frost free refrigerator as this kind of refrigerator will bring frequent temperature changes on the samples. 2.3.14 Serum samples shall be stored in sealed tubes. 2.3.15 All calibration solutions for the instrument should be stored in 5℃~25℃ and clean environment. Direct sunlight and long-term open in the air must be avoided. 2.3.16 The increase in salicylate and its derivatives and bromide content in the sample increases the chlorine reading, which may be the contamination of the sample with perchlorate, thiocyanate, iodide or nitrate. 2.4 Factors that may affect the electrode 2.4.1 Ionized calcium(iCa2+)and total calcium(tCa2+) Between 40-50% of the calcium in plasma is protein-bound, and 5-10% is in the form of complexes with organic acids and phosphates. The remainder (40-50%) is ionized. Ionized calcium is a physiologically active form of calcium, many important physiological processes such as the formation and absorption of bones, nerve conduction, muscle contraction, serum coagulation and many enzyme activity and so on with the activity of Ca2+. As the iCa2+ reflected more patient's clinical symptoms and calcium metabolism than tCa2+, so the determination of serum iCa2+ has more clinical significance than tCa2+. Determination of tCa2+ usually by EDTA solution, colorimetric or atomic absorption spectroscopy. In a certain range (pH 7.0 ~ 8.0), iCa2+ and pH changes were negatively correlated. When Serum pH increased (every 0.1 pH units), ionized calcium concentration decreased of about 4-5%. By detecting the pH of the serum sample, the actual ionized calcium value, actually, the standard ionized calcium value ( pH = 7.40, the normalized calcium value; nCa2+), and tCa2+ ≈ 2×nCa2+ (Here, tCa2+ is a derived value, can’t use for clinical diagnosis, for reference only), when the serum pH> 8.0, the nCa2+ results may high, while measuring iCa2+<0.85mmol/L or iCa2+>1.5 mmol/L, the tCa2+ cannot be used as a reference and is recommended to be measured Page 12 in other ways. As time goes by, carbon dioxide escape from serum, pH rose high, and the iCa2+ is lower, this will affect the test results. So the serum should be measured as soon as possible, not more than an hour as to avoid the pH effects. Note: Different batches of serum quality control, their pH values are different, so tCa2+ cannot be calculated by iCa2+. Factors influencing iCa2+ determination: ① Sampling: fasting, no tourniquet. (Diet, intravenous congestion, upright, etc. can make iCa2+ increased); ② Time: the sample should be measured as soon as possible after sampling, it is best not to more than 1 hours; ③ Anticoagulant: do not use EDTA, citrate, oxalate as anticoagulant, heparin concentration should not be too high (10IU/mL or so). Hypercalcemia: hyperthyroidism, malignant tumors, poliomyelitis, vitamin D intoxication and so on. Hypocalcemia: kidney disease, vitamin D deficiency, intestinal malabsorption, hypoparathyroidism and so on. The results of serum samples: Hypoparathyroidism: tCa2+ ↓ ↓, nCa2+ ↓ ↓ Hyperparathyroidism: tCa2+ ↑, nCa2+ ↑ ↑ Vitamin deficiency: tCa2+ ↓, nCa2+ ↓ Vitamin D intoxication: tCa2+ ↑, nCa2+ ↑ Chronic nephritis: tCa2+ ↓ ↓, nCa2+ ↓ ↓ Malignant neoplasms: tCa2+ ↓ ↓, nCa2+ ↑↑ Hypoproteinemia: tCa2+ ↓, nCa2+ normal, hyperproteinemia: tCa2+ ↑, nCa2+ normal Atherosclerosis: tCa2+ ↑, nCa2+ ↓ Pregnant women: tCa2+ ↓, nCa2+ ↓ In addition: Surgical patients, organ transplant patients need to enter a large number of citrate anticoagulated whole serum tCa2+ normal, iCa2+ ↓. Page 13 Pediatric rickets patients TCa2+ normal, iCa2+ ↓. People under the age of 45, iCa2+ basic normal, and later with the age of growth and gradually reduced. Patients with acute pancreatitis TCa2+ change is not obvious, iCa2+ ↓ ↓, and is proportional to the severity of the disease. The results of blood samples: Acute respiratory acidosis: TCa2+ and Alb normal, pH ↓, iCa2+ ↑, nCa2+ normal. Acute respiratory alkalosis: TCa2+ and Alb normal, pH ↑, iCa22+ ↓, nCa2+ normal,, pCO2 ↓. Acute metabolic acidosis: TCa2+↓, pH ↓, iCa2+ normal, nCa2+↓. 2.4.2 Some factors that may affect the electrode Analyte K+ Na+ Cl- Interferent A hemolysis occurred in the sample Heparin potassium anticoagulant Contamination in container Procaine Ammonium carbonate Nystatin Amphotericin Lidocaine Perchlorate Benzalkonium chloride Thiopental sodium Heparin sodium anticoagulant Contamination in container Bromide Ammonium carbonate Benzalkonium chloride Thiopental sodium Contamination in container Bromide Nitrates Salicylate Ammonium carbonate Iodide Thiocyanate Perchlorate Citrate Acetylcysteine Page 14 Effect On Analyte Result Increase (↑) Increase (↑) Increase (↑) Decrease(↓) Increase (↑) Increase (↑) Increase (↑) Decrease(↓) Decrease(↓) Increase (↑) Decrease(↓) Increase (↑) Increase (↑) Increase (↑) Increase (↑) Increase (↑) Increase (↑) Increase (↑) Decrease(↓) Increase (↑) Increase (↑) Decrease(↓) Increase (↑) Increase (↑) Increase (↑) Decrease(↓) Decrease(↓) iCa2+ Li+ pH Contamination in container Procaine Bromide Salicylate Ammonium carbonate Nystatin Amphotericin Lidocaine Thiocyanate Perchlorate Benzalkonium chloride Thiopental sodium Acetylcysteine Acetaminophen Magnesium Lactate Heparin lithiumanticoagulant Contamination in container Thiopental sodium Halothane Increase (↑) Decrease(↓) Increase (↑) Decrease(↓) Decrease(↓) Decrease(↓) Decrease(↓) Decrease(↓) Decrease(↓) Decrease(↓) Increase (↑) Decrease(↓) Decrease(↓) Decrease(↓) Increase (↑) Decrease(↓) Increase (↑) Increase (↑) Decrease(↓) Decrease(↓) Page 15 Chapter 3 Working Principle 3.1 Flow Path 1) After a sample is sucked into the Measuring Chamber, there are Li+, K+, Na+, Ca2+, pH, Cl-, Ref inside for seven electrodes. (each type electrode vary) in response to samples of the Li+, K+, Na+, Ca2+, pH, Cl-, Ref. These signals will display the testing results after amplification analog to digital conversion and after being sent to the microcontroller for statistics and calculation. The printer will print the results accordingly. 2) After a sample and reaction solution are sucked into TCO2 reaction cell, the HCO3- ion and the reaction solution are in the full reaction after mixing to generate CO2. The pressure inside the TCO2 reaction cell changes accordingly and will attract the pressure sensor. These signals will display the testing results after amplification analog to digital conversion and after being sent to the microcontroller for statistics and calculation. The printer will print the results accordingly. 3.2 Measuring Principle Page 16 3.2.1 Reference Electrode [Introduction] The reference electrode is made up of a small silver bar (coated with AgCl) dipped in KCl saturated solution and along with a cellulose diffusion membrane. [Principle] In the solution of Cl- ion solubility unchanged, the reference electrode to maintain a constant potential. In the process of measurement, the sample and KCl solutions have diffusion potentials as the diffusion rate of each ion are different. The potential is sent to the measuring device so that the potential and REF electrodes can be compared. The potential of reference electrode potential will change with the extension of time. But the change in the relative measurement error will not bring significant. 3.2.2 pH Electrode [Introduction] The pH electrode adopts ion selection technique (ISE). It constitutes an electrochemical cell with external reference electrode. It consists of Ag/AgCl core soaking in a buffer with constant H+ concentration and a H+ sensitive membrane. [Principle] pH electrode measures the concentration of hydrogen ions in the sample according to the changes of voltage on the sensitive membrane. H+ ion sensitive membrane will separates buffer solution and sample. When the sample contacts the sensitive membrane of pH electrode contact, half-cell potential is generated due to H+ ion exchange. The potential is sent to the measuring device and compared with the potential of reference electrode. The potentials of the two electrodes reflect the H+ ion concentration in the sample solution and pH value of the sample is calculated. The voltage of a reference electrode is always constant. The relationship between voltage and pH at a special temperature can be calculated by the Nernst formula. [Nernst Formula] pH: H+2O ⇋ H+ + OHpH=-lg[a H ] 。 , at 25℃, the ion product constant Kw = 10-14,define Nernst Formula RT lg a H ZF E = Measured voltage (mV) E=E 0 2.303 Page 17 E0 = Standard voltage (mV) R = Gas Constant (8.314 J mol-1 K-1) T = Temperature Z = The ion charge F = Faraday constant (96458 C mol-1); a = Ion activity Therefore, at 37℃(310K), ⊿E=-61.5⊿pH(mV),a voltage of 61.5 mV is developed for every pH unit difference. 3.2.3 ISE [Introduction] The analyzer includes ion selective electrodes to measure Li+, Na+, K+, Ca2+ and Cl- ion concentration in human blood. Each ion selective electrode has the external electrode as reference. Li+, Na+, K+ and Ca2+ electrodes have solid sensitive membranes of ion selective. The Cl- electrode contains electrolyte materials and is covered with an ion selective membrane. [Principle] The ion sensitive membrane has high selectivity through capacity. Proportional relations are applicable between the concentration of ionic signal and the of the electrode output of sample. This conforms to the Nernst formula. [Nernst Formula] The sensitive membrane potential in the electrolyte electrode in the differential can be calculated as RT log e [a ion ] ZF E=Measured voltage (mV) E0= Standard voltage (mV) R= Gas Constant (8.314 J mol-1 K-1) T=Temperature Z=The ion charge F= Faraday constant (96458 C mol-1); a =Ion activity E E0 Page 18 Chapter 4 Technical Feature This chapter presents major features and parameters of AFT-800D series analyzers. 4.1 Parameter 4.1.1 Measured Parameter Parameter Li+ K+ Na+ Ca2+ ClpH TCO2 Description Lithium Potassium Sodium Calcium Chloride Hydrogen Total carbon dioxide 4.1.2 Calculated Parameter Parameter AG 2+ Ca (7.4) TCa2+ Description Anion Gap Ca2+ corrected Total Ca2+ 4.1.3 The normal ISE concentration range of Serum Parameter K+ Na+ CliCa 2+ Unit Range mmol/L (3.50~5.50)mmol/L (3.50~5.50)mEq/L mEq/L mmol/L (135.00~145.00)mmol/L (135.00~145.00) mEq/L mEq/L mmol/L (96.00~106.00) mmol/L (96.00~106.00) mEq/L mEq/L mmol/L Adult:(1.10~1.35)mmol/L (4.40~5.40)mg/dL mg/dL nCa 2+ mmol/L Adult:(1.10~1.35)mmol/L (4.40~5.40)mg/dL mg/dL Adult:(2.20~2.70)mmol/L TCa2+ Li+ mmol/L (8.80~10.80)mg/dL Infant:(2.25~2.67)mmol/L (4.40~5.40)mg/dL mg/dL mmol/L (0.00~0.30) mmol/L (0.00~0.30) mEq/L mEq/L 7.35 ~ 7.45 pH Page 19 mmol/L TCO2 (20.00~29.00)mmol/L (20.00~29.00) mEq/L mEq/L mmol/L AG (8.00~16.00) mmol/L (8.00~16.00) mEq/L mEq/L 4.1.4 Testing range Parameter Testing Range K+ (0.5~15.0)mmol/L Na+ (20.0~200.0)mmol/L Cl- (20.0~200.0)mmol/L Li+ (0~3.0)mmol/L Ca2+ (0.1~5.0)mmol/L pH 6.0~9.0 TCO2 (6.0~50.0)mmol/L 4.1.5 Electrode Parameters Electrode Normal Range Limit for New Refilling Solutions Li+ 50 mV~140 mV < 50mV or >140mV +5.0mV~+9.0mV + K Slope Range 45mV~140mV <45mV or >140mV +12.0mV~+21.0mV + 45mV~120mV <45mV or >120mV -4.2mV~-7.3mV 2+ 35mV~100mV <35mV or >100mV +6.6mV~+10.5mV Cl- 50mV~120mV <50mV or >120mV +5.4 mV~+10.8mV pH 70mV~170mV <70mV or >170mV +16.0mV~+28.0mV Na Ca 4.2 Sample type Serum samples from human blood 4.3 Test Speed 40 samples per hour 4.4 Minimum sample volume 80μL 4.5 Output Liquid crystal display, built-in thermal printer and RS232 output Page 20 4.6 Dimension and weight Main Unit (Length×width×height):344mm×283mm×455mm Autosampler (Length×width×height):335mm×192mm×372mm Net weight of main unit:13kg Net weight of autosampler: 4.8kg 4.7 Fuse 2×F3.15AL250V。 4.8 Memory RAM of 8Kb, flash of 116Kb。 4.9 Display Resolution 800×480; touch screen of 7 inch 4.10 Communication Agreement HL7 and Own-Protocol 4.11 Printer Automatic thermal printer Paper width:30 mm(W) × 57 mm(D); Speed:15mm/s; Resolution:240×128 Pixels Page 21 Chapter 5 Installation 5.1 Unpacking Steps of unpacking: 1. To check whether the outside carton is intact or not. 2. To check the quantity and quality of all items according to the packing list. Please contact the local distributor if anything is absent or broken. 3. Carefully take out the analyzer. Place it on a dry platform. Let the panel be close to the power socket. 4. Check the outside power part : 1) Switch the multimeter to AC 750V position. 2) Connect the power as the picture: 3) Insert the red pen (positive pole) of multimeter into the live wire on the other end and insert the black pen (negative pole) into the hole neutral wire. It is normal if the multimeter shows the voltage between the neutral wire and live wire is 220V (or 110V, depends on electric supply). 4) Insert the red pen (positive pole) of multimeter into the ground wire inlet while keep the black pen(negative pole) unchanged. It is normal if the multimeter shows the voltage between the ground wire and the neutral wire is 1V. Page 22 5) Then insert the red pen into the live wire inlet while insert the black pen into ground wire hole. It is normal if the multimeter shows voltage between the grounding wire and the live wire is 220V (or 110V, depends on electric supply). The analyzer shall be installed by the professional engineer of the distributor. The distributor can send some engineers to Cornley for necessary training before installation. 5.2 Installation of Accessories 1. Installation of electrodes Please refer to 5.3 2. Installation of pump tubes Please refer to 5.4 3. Installation of printing paper Please refer to 5.5 4. Installation of reagent Please refer to 5.6 5. Installation of auto-sampler Please refer to 5.7 7. Please put the scanner beside the analyzer as a stand-by 7. Switch on: 1) Switch off the power and battery first 2) To connect one end of the power cord to the back of the analyzer while plug the other end into the power supply inlet. 3) Switch on the power and battery to start the analyzer. There must be an adjustment on touch screen for the first usage. The analyzer will start a self test after such adjustment (please refer to 6.2 for the details about self test). The analyzer must use three core power cord. The power grounding must be correct. Incorrect grounding may result in electric shock or analyzer damage. Please confirm the power supply inlet is qualified enough for the analyzer. The fuse must be installed to the analyzer before power-on. Please remain power-off for the analyzer before the connection of power cord. 5.3 Installation of electrodes According to different functions, the electrodes can be grouped as below: Page 23 ISE electrodes: K+/Na+/Cl-/Ca2+/pH. Refillable.The K+, Cl-, Ca2+ electrodes need to refilling solution before installation. When solution less height than 1/2, user need to dry the electrode and refill .The refilling solution has to be replaced for every 3 months. Reference electrode: Fixed type with internal solution. The steps to add refilling solution to ISE electrodes: 1) Open the contact terminal of Li+, K+, Na+, Ca2+, pH, Cl- electrode (taking Na+ electrode as the example in the pictures): 2) Empty the internal electrode solution. 3) Step1 Step 2 Cut the bottle of refilling solution with a scissors. Use a syringe to aspirate the liquid. 4) Use the syringe to inject refilling solution into the electrode (The needle of the syringe can never touch the bottom of the electrode. Otherwise the membrane may be broken) 5) Step 3 Step 4 To dry the rest refilling solution on the terminal of electrode by tissue paper. 6) The electrode terminal must be properly tightened. Then seize the electrode to upright position. Please click the bottom of electrode several times with a finger to remove bubbles at the bottom of the inner cavity of the electrode. 7) To dry the rest refilling solution on the electrode by tissue paper again. Page 24 Step 5 Step 7 The steps to add refilling solution to Ref electrode: a) Spin out the cap and terminal of Ref electrode b) Open the small bottle of refilling solution for Ref electrode. Use a sucker or a syringe to aspirate the liquid. c) After the smaller inner cavity of the Ref electrode is filled with refilling solution to the inner cavity mouth, please tighten the electrode terminal of this side first. Then added some more refilling solution to 4/5 of the inner cavity of the bigger side and tighten the electrode terminal of this side. d) Seize the electrode to upright position. Please click the bottom of electrode several times with a finger to remove bubbles at the bottom of the inner cavity of the electrode. e) The refilling solution for Ref electrode is an oversaturated solution. There will be white crystal inside the inner cavity of the electrode during the usage. The refilling solution may volatilize after long time usage. So please add refilling solution for Ref electrode one time. (When replace refilling solutions for ISE electrodes, the original liquid inside the electrodes must be empty first. However, it is OK to add refilling solution for Ref electrode directly no matter the electrode is empty or not. Please notice that the refilling solutions for ISE electrodes and Ref electrodes are different. Please only add correct refilling solution to the correct electrode(s).) 8) After inject enough refilling solution into the electrodes, please install them into the measuring chamber according to the order (from left to right) of Li+, K+, Na+, Ca2+, Cl-, pH and Ref. Installation steps: Page 25 1. Open the front cover of the analyzer and the cover of measuring chamber. 2. For the first usage of all electrodes, or the refilling solution in one electrode is less than half of its inner cavity, new refilling solution must be injected into the electrode(s). 3. Before installation, please use a clean paper towel to clean the measuring chamber and the electrode terminal. 4. Pull the spanner to right 5. Check whether the O-rings on the both sides of each electrode are normal or not. Use a tissue paper to clean the channel of each electrode. 6. Place the electrode head tightly against spring. Then press to inner side and trim all electrodes from left to right according to the correct order. 7. Install the Ref electrode at last. 8. Level all electrodes again when all of them are installed into the right places. 9. Release the hand slowly so that the spanner can press all electrodes tightly. 10. Check whether all electrodes are leveled or not at last. 11. Close the cover of the measuring chamber. Electrodes shall maintain a channel end to end to form of a Flow path (no dislocation) After installation, please check whether there is any bubble at the bottom of every electrode. If yes, please tap the bottom of the electrode several times to remove the bubble. Correct position of each electrode is shown in the picture below. Page 26 The replacement of the electrode is similar to the installation. The parameter of each electrode is in 4.1.5 section. 5.4 Installation of pump tube The steps of pump tube installation are as below. 1. Please wrap the pump tube to the peristaltic pump. (To avoid failure due to long-term taut, the tube must be removed from the peristaltic pump during transportation). 2. Rotate the wheel of peristaltic pump to card the tube into the pump wheel slowly. When the whole tube is carded into the wheel, card the other end into peristaltic pump. 3. Rotate the pump wheel anticlockwise first and clockwise later until the tube is rotated just in the middle of the wheel. 4. Check whether the ends of the pump tube are in the correct position or not. 5. Insert the Tygon tube into the joint pipe of pump tube for at least 5 mm. Please remain power-off during the installation of pump tubes. 5.5 Installation of printing paper The steps to install printing paper are as below. 1. Push the open key on the printer and open the cover of the printer. 2. Load a new roll of paper inside the compartment. Please notice that thermal surface of the paper must be upward (use a hard objects scratches both sides of the paper. The side with black scratch is thermal surface). Step 1 Step 2 3. Drag the paper out for about 3 cm. Page 27 4. Steady the paper and close the printer cover. 5. Tear off the redundant paper Never pull the paper from inside. It may damage the gear of the printer. 5.6 Installation of Reagents 5.6.1 Installation of calibration solution Generally, please always remain power-on for the analyzer. If the analyzer is power off for more than 24 hours, there may be crystal in Flow path. The barcode for each calibration solution cannot be used again after a successful installation. The steps to install/replace calibration solution: 1. Open the front cover of the analyzer, release the reagent connector, and take out the previous pack. (Ignore this when install the first pack of calibration solution) 2. Hold a new pack at hand. Tap the “consumable” on the main menu to enter the sub-menu of consumable management. Use the scanner to scan the bar code on the pack. 3. Remove the sticker “please remove before usage” on the new pack and expose the exhaust holes of the pack. Remove the plastic cover over the pack connector. 4. Connect the pack connector with the reagent connector of the analyzer. 5. Place the plastic cover of the new pack over the pack connector of the old pack to seal the waste inside the old pack. Page 28 Do wear gloves when replacing the packs. Put the old pack in upright position and cover its connector with the plastic cover once it is taken out. Please destroy the old packs according to relevant local laws. 5.6.2 Installation of TCO2 Reaction Solution Place the bottle of TCO2 reaction solution at the front groove of the analyzer. Get through the tubes then. 5.7 Installation of autosampler 1. Connect tube 1 with the upper interface of the sample probe of the autosampler, connect the tube 2 with the lower interface of the manual sample probe. Please ensure the joint length of each point is ≥5mm as the picture below Page 29 2. Lift up the autosampler and hook on the the analyzer. 3. Connect two sockets of auto sampling on the analyzer and the autosampler with the data cable. Never connect these two sockets when the analyzer is power on. 4. Lift the autosampler by the handle. Set the positioning hole right on the positioning pin at the bottom. Then flat the handle as the picture below. Page 30 5. Match the gap on the cover of autosampler to the gap of the autosampler. Place the cover over the sampler and confirm it is fixed. Autosampler is only for the automatic models. The sampler disc can only be taken out when the handle is totally upright. Never remove the cover of autosampler during testing. Otherwise the test will be halted automatically. The test will only be continued when the cover is correctly placed again. Page 31 Chapter 6 Main Menu 6.1 Power on This analyzer uses colorful touch screen. After install the analyzer, connect the power and power on, the interface will show the logo, and two seconds it will show self test menu. 6.2 Self Test The self test of the analyzer includes the checks on sampling module, motor module, sensor module and liquid level detection module. Flush and calibration solution is aspirated and emptied to set up liquid and air reference with the cooperation of pumps and multiplexer. After any step of this self test, the analyzer will show the test result, pass or fail. After a successful self test, the analyzer will into the calibration process automatically. 6.3 Main Menu When the analyzer completes the self test and calibration, it will enter the main menu, Menu bar: display the consumables status (CAL pack, pump tube and electrodes) and troubleshooting tips. Center section: display Test, QC, Calibration, and other menu, etc. Page 32 Status bar: display system time, status message and maintenance tips. 6.4 Test Menu 6.4.1 Place the Probe Cleanser at 25 cup 1) The Probe Cleanser applies to the J25 type autosampler tray of electrolyte analyzer, which is used to clean the probe of autosampler, and eliminate blockage in the probe. 2) Take out the Probe Cleanser, carefully open cap and put the Probe Cleanser at 25 cup. Change another Probe Cleanser in 3 days. 6.4.2 Serum test 1) Tap the “Test” button of the main menu. The analyzer will enter the test menu as the picture below, select the testing parameter. Tap the “Cup choice” to select the desired cup number and place the sample in the correct position. 2) Tap “Sample ID” to input the ID of the sample. 3) Place the sample into the right position and tap “Start” button directly. The sample will be aspirated into the measuring chamber. Then the color of each cup means: White indicates that there is no sample; Pink indicates that the sample is testing now; Blue indicates that the sample is not tested yet; Grey indicates that the sample has been tested. After the test, the result will be printed automatically. Also, you can check the results by tapping the sample number. Page 33 6.4.3 Emergency test 1) For urgent sample, the user can tap “STAT” button as below: 2) Place the urgent sample on the empty position (like number 9), input the number accordingly. Step 1 3) The rest steps are the same as 6.4.1. Step 2 6.5 QC Tap the “QC” button of the main menu. Then tab the button in the left top corner, the analyzer will enter the “QC Plot” or “QC TEST” as below: 6.6.1 QC Plot 1) Tap the “QC LOT Manager” to add, view, edit or delete a QC Lot, Target: Page 34 3) Select the desired QC LOT, then place QC solutions on the right position,”Level 1” correspond with (# 25 QC1), “Level 2” correspond with (# 24 QC2), “Level 3” correspond with (# 23 QC3). 4) Then tap “Test” button to test the QC solutions. 5) Tap the “QC Plot Datas”, the user can view, delete and transfer the results to LIS. 6) Tap the “QC Graph” to view Levey–Jennings graph: Page 35 6.6.2 QC Test 1) Select the desired QC LOT and test number for each level, then place QC solutions on the right position,”Level 1” correspond with (# 25 QC1), “Level 2” correspond with (# 24 QC2), “Level 3” correspond with (# 23 QC3). 2) Then select “Level 1”, “Level 2”, “Level 3” or “All Level”,press “Test” button to test the QC solutions. 3) Tap “QC Datas” button then select the date to view the test results: 4) Tap “Statistics” button to calculate each level’s CV. 5) Tap “Calculation” button (pass word: 88), the user can get “Correlation Coefficient” of each parameter, please check “6.7.9 Correlation Coefficient Configuration” for detail: Page 36 6.6 Maintenance Menu To obtain high reproducibility of measure results and high stability of sensors, it is essential to maintenance the unit regularly. Tap the “Maintenance” button of the main menu to enter the submenu of maintenance. 6.6.1 ISE Deproteinization Use this procedure to clean the sample path with deproteinization solution once 10 days or every 100 samples. Deproteinization removes protein buildup from the sample path. Wait 10 minutes for the ISE Deproteinization cycle to finish. Caution: The deproteinization solution is for single use. Page 37 6.6.2 Flush Tap the “Flush” button, the flow path will be flushed automatically. 6.6.3 Deep cleaning Tap the “Deep cleaning” button, the analyzer will show as follows. Wait 10 minutes for the deep cleaning cycle to finish. 6.6.3 ISE Cleaning Tap the button “ISE Cleaning”, the analyzer will aspirate cleaning solution automatically. Wait 5 minutes for the ISE Cleaning cycle to finish. 6.6.5 Na&pH conditioning “Na&pH conditioning” works for Na and pH, place the Conditioning solution in #22 Page 38 cup. Wait 5 minutes for the Na&pH conditioning cycle to finish. Caution: The Na&pH conditioning is for single use. 6.6.6 Serum soak Tap the “Serum soak” button, prompt will instruct the user to place Serum in #21 cup. Wait 10 minutes for the Serum soak cycle to finish. 6.6.7 One_ Key_Maintenance Tap the “One_Key_Mainteinance” button, the analyzer will perform “All Cleaning”, “ISE Deproteinization”, “Na&pH Conditioning”(if triggered) , “Serum soak”. Wait 45 minutes for the One_Key_Maintenance cycle to finish. Page 39 6.6.8 TCO2 Deproteinization After long-term use, protein buildup in the reaction cup.Please remove protein regularly. Wait 5 minutes for the TCO2 Deproteinization cycle to finish. 6.6.9 All Cleaning Tap the “All Cleaning” button, the analyzer will perform “ISE Cleaning”,”TCO2 Cleaning” and flow path cleaning. Wait 20 minutes for the All Cleaning cycle to finish. 6.7 System Setup Return to the main menu, tap “System Setup” button to enter the submenu of system configuration. The analyzer has 16 parameters for the user to meet various demands of clinical diagnostics. Page 40 6.7.1 Reference Range Configuration At the submenu of system configuration, tap “Reference Range” button to enter the screen of reference range configuration. Tap “Reset” button for the default reference range. 6.7.2 Printer Setup At the submenu of system configuration, tap “Printer Setup” button to enter the screen of printing configuration. The user can choose “PRINT ITEM”, “Print Reference Range” and “Printer Switch”. 6.7.3 Unit Configuration At the submenu of system configuration, tap “Unit Setup” button to enter the screen of unit configuration, the analyzer provides a variety of units for measured parameters. Page 41 6.7.4 Screen Configuration At the submenu of system configuration, tap “Screen” button to enter the screen of Screen configuration. “LCD Brightness” can be adjusted by user. 6.7.5 Testing Parameter At the submenu of system configuration, tap “test parameter” button to enter the screen of test parameter configuration. The user can select measured parameters. 6.7.6 Maintenance Setup At the submenu of systematic configuration, tap “Maintenance Setup” to adjust the days or sample tested counts. Page 42 6.7.7 Date&Time Configuration At the submenu of system configuration, tap “Time&Date” button to enter the screen of time configuration. The user can modify date and time in the analyzer. 6.7.8 QC Control Configuration At the submenu of system configuration, tap “Quality Control” button to enter the screen of QC Control configuration. ⑴13s This rule is commonly used with a Levey-Jennings chart when the control limits are set as the mean +3 standard deviations of control limits. A run is rejected when a single control measurement exceeds the mean +3 control limits. ⑵22s The control run is rejected with 2 consecutive control measurements 2 standard deviations of control limits on the same side of mean with this rule. Page 43 6.7.9 Correlation Coefficient Configuration At the submenu of system configuration, tap “Correlation Coefficient” button to enter the screen of Correlation Coefficient configuration (password: 88). This setup screen allows the user to mathematically adjust the analytical results of the analyzer based on results from a reference analyzer or reference material. The correlation coefficients can be specified for slope and intercept for each measured parameter. The correlation coefficients of K+, Na+, Cl-, Ca2+, Li+, pH and TCO2can be calculated automatically. Please refer to chapter 7 for details. Tap “Reset Slop” button for the default correlation coefficients of K+, Na+, Cl-, Ca2+, Li+, pH and TCO2. Tap “Reset K-value” button for the default K-value. 6.7.10 Calibration Intervals Configuration At the submenu of system configuration, tap “Calibration Intervals” button (password: 88) to enter the screen of Calibration Intervals configuration. The user can select frequency of one-point calibration. The system default interval for one-point calibration is 240 minutes, while two-point calibration interval is fixed four hours. The user can define system standby time, during the time there only liquid movement. The system default interval for Li-K value is 7 days, please refer to chapter 7 for details. Page 44 6.7.11 Sampling Mode At the submenu of systematic configuration, tap “Sampling Mode” to select “Auto” or “Manual” mode. 6.7.12 Sample Volume Configuration At the submenu of system configuration, tap “Sample Volume” button to enter the screen of sample volume configuration. The user can select the volume of sample aspirated, which is increases from 1 to 5. 6.7.13 Resistance Setup For customer service staff. 6.7.14 Data Transfer Mode At the submenu of system configuration, tap “Data Transfer Mode” button to select the “HL7 Mode” or “Self Mode”: HL7 Mode: Tranfer the data to LIS (Laboratory Information System). Self Mode: Tranfer the data to the Data management software developed by Cornley. Page 45 6.7.15 Operation Mode At the submenu of systematic configuration, tap “Operation Mode” to select “Economization” or “Standard” mode: In “Standard mode”, during the sample test, the analyzer will aspirate Cal A to start a background 1-Point calibration for a more accurate test result than “Economization Mode”. But it will consume more Cal A and take about 12 seconds more than “Economization Mode”. 6.7.16 Other At the submenu of systematic configuration, tap “Other” to select “Bubble”, “TCO2 Pathway”, “Clog”, “TCO2 Res”. 6.8 Data Manager Tap “Data Manager” button of the main menu to enter data management section. Page 46 6.8.1 Test Result Tap “Test results” button at data management menu to enter test results search interface: 1. The upper side of the interface is the search field. The user can search by time period and "PID" (Patient ID). The middle part is to display test results. The lower part is for function keys. 2. Input PID or test date then tap “search” button to search relevant data. 3. Tap “Print” to print the test result. Tap “LIS” to transfer the test result. 6.8.2 ISE Calibration Results 1. Tap “ISE CAL Results” button to enter ISE calibration result search interface: 2. Input calibration date and search relevant data. 3. Tap “Print” to print the test result. Page 47 6.8.3 TCO2 Calibration Results Similar to ISE CAL Results, which is used for checking calibration results of TCO2. 6.8.4 Test Results Transmission Tap “Test Results Transmission” button to transfer the data of the selected date. 6.9 Service Return to the main menu, tap “Service” button to enter the submenu of Servers: 6.9.1 ShutDown Tap “ShutDown” button to shutdown the system: Page 48 Take off Calpack, link the connector in the accessory box. Put all entry pipes(Cal A, Cal B, TCO2 and Cleaning solution) in distilled water, and put waste pipe in a cup or bottle. Then remove distilled water, leave all entry pipes in the air to evacuate the flow path. 6.9.2 Version Tap “version” button to check the software verison: 6.9.3 Help Reserved. 6.9.4 Tools For customer service staff. 6.9.5 Self Test Tap “Self Test” button to check on important parts automatically. If the self test is OK, the analyzer will return to main menu automatically. If not, please remove all troubles according to the hint on the screen. Page 49 6.9.6 Sample Needle Adjust Tap “Sample Needle Adjust” button to adjust the probe if its position is shifted. Press “Sample Frame Transposition” button and then press “Left” or “Right” button to make the probe align the center of its dock. 6.9.7 Sample Tray Adjust Tap “Sample Tray Adjust” button to adjust the sample tray if its position is shifted. First Cup 25 is adjusted, press “Right” or “Left” button to make the probe to align the center of Cup 25 .Then adjust position Cup 1. Press OK to save. 6.9.8 Multiplexer Check Tap “Multiplexer Check” button to check whether the multiplexer can aspirate Cal A, Cal B, TCO2 Cal and Cleaning solution. Page 50 6.9.9 Cal Pack Used Tap “Cal Pack Used” button to check out remaining of cal pack. 6.9.10 TCO2 Clog Check Tap “TCO2 Clog Check” button to check out whether the gas flow path is clogged or not. 6.10 Consumables Management 1. Tap “Consumables Management” at the main menu, and scan the barcode on the consumables, tap “List” button to check state of current consumables: Page 51 3. Tap “Manually Barcode” button to input the barcode if there is problem with the barcode scanner. Page 52 Chapter 7 Calibration 7.1 General information Calibration defines both points of Cal A and Cal B. When calibration is passed, the concentration in an unknown sample can be calculated from the two points via Nernst equation. The voltage (mV) difference between Cal B and Cal A should fall within the requirement to ensure linearity range of electrodes. The response relationship between voltage and ion concentration is shown as below Generally, if the slope of measured parameters by an electrode (or sensitivity) and drift rate (output electrode signal of the parameter) is known, the unknown value can be calculated by measuring the electrode. Electrode calibration is a process to obtain slope and drift rate from the output signal of the electrode associated with liquid concentration. Two-point calibration solution is used by this analyzer to achieve this goal. 7.2 One point calibration One point calibration can associate mV values with ion concentration of Cal A. It defines the first point of two point calibration. It is also used to check the status of electrodes after two point calibrations is passed. The step of one point calibration is as follow: 1. Tap “1 Point Calibration” button at the submenu of calibration. Page 53 2. The analyzer will aspirate calibrator automatically. 3. The calibration result will be printed after one pint calibration is done. 4. The analyzer will aspirate flush solution automatically to flush the Flow path. 5. When the flush is done, system will return to the main menu automatically or wait for the further command from the operator There are four possibilities for one point calibration Pass Unstable Drift OR: mV out of range The system will display the corresponding concentration of Cal A and return to the main menu. Unstable mV value. The system will also alarm voltage value is unstable When two mV values are beyond a certain range, the system will alarm the electrode drift. The abnormal electrode channel will be displayed at the bottom of the screen. If the electrode mV value exceeds the set range, the system will prompt the mV is out of range. Please refer to the following instructions for the range of each electrode. Notice: “Cal A”:”A1” here means the first one point calibration “02:01”: Calibration time “Voltage”: Potential (mV) of the electrode “Value” : The concentration of ion, unit mmol/L。 “Status”: Status of calibration, show “PASS” when the calibration passes or “FAIL” when the calibration fails. 7.3 Two point calibration Two point calibration is necessary before testing or QC on Li+, K+ ,Na+ , Ca2+,pH ,Cl- ,Two point calibration includes calibration A and B. 1. Tap “two point calibration” button at the submenu of calibration; 2. The analyzer will do Cal A (the same as one point calibration); 3. When the Cal A passes, the analyzer will do Cal B automatically; 4. The analyzer will aspirate Cal B to perform the calibration; Page 54 5. The calibration result will be printed after two pint calibration is done; 6. The analyzer will aspirate flush solution automatically to flush the flow path; 7. When the flush is done, system will return to the main menu automatically or wait for the further command from the operator. There are five possibilities for two point calibration: The system will display the corresponding concentration of Cal A /B and return to the main menu. The system is ready for test Unstable mv value. The system will also alarm voltage value is unstable Pass Unstable When two mV values are beyond a certain range, the system will alarm the electrode drift. The abnormal electrode channel will be displayed at the bottom of the screen. Drift If the electrode mV value exceeds the set range, the system will prompt the mV is out of range. Please refer to the following instructions for the range of each electrode. Difference on MV between Cal B and Cal A is called slope. If the difference exceeds the prescribed range, it is called the slope abnormal. Please refer to the following instructions. OR: mV out of range Slope Abnomal 7.4 Li_K Value Adjustment This menu is applicable to perform Lithium calibration only. 1. Perform ISE Two point calibration. Continue to next step if it is passed with one trial only. 2. Enter “Main Menu→QC Test”, test QC level1/level2/level3. If Na is in the range, then continue to next step. If Na is out of range, then perform Na correlation as section 6.7.9 and 6.6.2. 3. 4. Feed selective coefficient calibrator (for Li+) to the #25 cup, enter Calibration and select Li_K test. 5. After 3 times of repeated K test, the result of K is automatically printed out and update the Li_K in “Correlation Coefficient” menu. Li is affected by the status of Na electrode. Make sure Na is stable and in the range when Li has problem. K test must be done after maintenance of Li and Na electrode. 7.5 TCO2 Calibration 1. Tap “TCO2 Calibration” button to enter TCO2 calibration menu 2. The analyzer will aspirate TCO2 standard solution to the reaction cup to perform the calibration on TCO2 3. Once TCO2 calibration passes, the result will be displayed and printed automatically 4. The analyzer will aspirate flush solution automatically to flush the flow path. Page 55 5. When the flush is done, system will return to the previous menu automatically. 7.6 ISE+TCO2 Calibration ISE + TCO2 Calibation will be two point calibration on ISE and TCO2 calibration. The analyzer must perform ISE + TCO2 calibration before test or QC. 1. Tap “ISE+TCO2 Calibration” button to enter ISE+TCO2 calibration menu; 2. The analyzer will perform two pint calibration on ISE as 7.3 section; 3. When two point calibration passes, the analyzer will perform TCO2 calibration; 4. The analyzer will aspirate flush solution automatically to flush the flow path; 7.7 Calibration Intervals This analyzer supports automatic calibration function, which is to keep and monitor electrode condition. The steps to set calibration interval is as follow, tap “System Setup” button at main menu: Tap “Calibration Intervals” button: 3. The system default interval for one-point calibration is 240 minutes, while two-point calibration interval is fixed four hours. 4. Tap “OK” button to save 7.8 Calibration Results Page 56 1. Tap “ISE CAL Results” or “TCO2 CAL Results” button at “Data Management” menu to enter calibration result search interface: 2. Input calibration time and search relevant data. 3. Tap “more” button to check more calibration data or to print these calibration results. Calibration type A1,2, or 3 B1,2, or 3 Description The first, second or third attempt on Cal A The first, second or third attempt on Cal B Page 57 Chapter 8 Patient Sample Analysis The sample analysis of this analyzer only needs three steps. The following describes only the analysis on sample but does not involve any sample type. The sample analyses on different types are nearly the same except for some minor differences. 8.1 Sample collection 1. Please refer to the blood collection standard procedures and Label the sample. 2. Let blood stand for 20-30 minutes to allow clot formation. 3. Centrifuge the tube for 10-15 minutes. Serum may be analyzed immediately, stored at 22-25℃ up to 8 hours. Please refer to chapter 2.3. 8.2 Steps of Sample Analysis 1) Tap the “Test” button of the main menu. The analyzer will enter the test menu as the picture below, select the testing parameter. Tap the “Cup choice” to select the desired cup number and place the sample in the correct position. 2) Tap “Sample ID” to input the ID of the sample. 3) Place the sample into the right position and tap “Start” button directly. The sample will be aspirated into the measuring chamber. Then the color of each cup means: White indicates that there is no sample; Pink indicates that the sample is testing now; Blue indicates that the sample is not tested yet; Grey indicates that the sample has been tested. Page 58 After the test, the result will be printed automatically. Also, you can check the results by tapping the sample number. 8.3 Test Result Tap “Test Result” button at data management menu to enter test results search interface: 1. The upper side of the interface is the search field. The user can search by time period and "Sample ID" (Patient ID). The middle part is to display test results. The lower part is for function keys. 2. Input sample ID or test date then tap “search” button to search relevant data. 3. Tap “more” button to check more details like basic information, test results, A5 test report, analysis report, edit, etc. Page 59 Chapter 9 Trouble Shooting This section covers the trouble shooting procedures of the instrument. The instrument can perform self test when power up. It will detect most of the problem except electrodes. 9.1 Normal Troubles and Solutions The instrument is not the control material factory production of corrected in the measured sample of some projects may be biased, need to readjust the project machine, belonging to the matrix effect is a normal phenomenon. to ensure the measurement results are accurate, the user shall regularly conduct quality control measure, usually once a day, in addition to the use of the company's quality control liquid and a variety of quality control serum, the standard of quality control liquid cannot use similar instrument equipped with measurement, because of some additives other standard solution which may cause unnecessary damage of electrode. As Li+ electrode test is modified by the Na+, when the Na+ electrode is abnormal, of the test results Li+ electrodes is not reliable. 9.2 Electrode The electrode may have some faults during testing on samples, especially complex samples. It will affect the measurement accuracy or even can not be measured at all. Please make correct judgment according to the fault phenomena, troubleshooting in time, make the instrument to maintain normal operation when there is electrode failure. 9.2.1 Drifting Activation time is not enough Increased activation time Electrode has the slight leakage To replace the new electrode Concentration change on Refilling Replace the refilling solution and enhance solutions the seal Reference electrode core coating goes off Replace the reference electrode core 9.2.2 Unstable 1) Electrode loose contact Wipe each contact with alcohol 2) Unstable power supply Install a regulator Page 60 9.2.3 Slow reaction and low slope 1) Electrode pollution Perform de-protein, conditioning to clean the electrode 2) Sensitive membrane damaged Replace a new electrode 9.3 A simple method to check respondent circuit channel of each electrode 9.3.1 To change the position of the normal electrode (such as Cl-) and unstable (mV variably) electrode (such as K+) between each other. Do a calibration and observe the display screen. 9.3.2 K display (the actual measured Cl-): If the mV value stability indicating K+ circuit is no problem, there may be a problem with K+ electrode. If the mV value is not stable description of K+ circuit problem, there can be no problem with K+ electrode. 9.4 Only one unstable electrode Solution: A. to do de-protein (K+, Cl-, Ca2+ electrode) or conditioning (Na+, pH electrode) B. to exchange the position of two electrodes, refer to the "common fault handling" If the problem can not be settled, please contact customer service department of Cornley for guidance and assistance 9.5 Two or more unstable electrodes The solution: A. De-protein or conditioning; B. Replace new calibration standard solution; C. Check reference electrode: whether there is leakage, bubble, not clean, silver bar peeling coating, or no liquid; D. Check the external power supply: whether the grounding or the regulator is installed well. 9.6 Longer balance time on Li+、K+、Cl-、Ca2+ electrodes Possible contamination, do de-protein immediately. 9.7 Longer balance time on Na+、pH Possible contamination, do conditioning immediately. Page 61 9.8 Problems on Flow Path There are two liquid-sensors in the measuring chamber. The front is used to check air bubble, while the back is used to check if the sample is arrived. If there is no sampl, both the liquid-sensor is 1.7±0.2V; When the sample arrived, both the liquid-sensor is below 1.0V. 9.9 Slope out of range Metamorphic standard solution, showed turbid, precipitation, to replace the new standard solution; electrode contamination must be to de-protein or conditioning. 9.10 Problems on Repeatability Electrode: eliminate the bubble in the bubble near the sensing membrane electrode. The sample mixed with bubble: find out reason, be removed. Reason: the test samples prepared with the new quality control samples or fresh serum. 9.11 Problems on Accuracy Interference of other substances in the sample: pay attention to sampling method. Standard concentration change: to replace a new calibration standard solution. Protein, lipid, deviation and flame photometer, may this deviation will be corrected according to ion electrode method for quasi. Correct parameter adjustment. 9.12 Problems on QC The analyzer is designed for fast and accurate measurement of human blood. Advanced technology that has good accuracy and repeatability in the linear range is quite wide. Page 62 To ensure that your analysis report has indisputable accuracy, you should regularly carry out quality control measure, usually once a day, in addition to the use of the company's quality control liquor, quality control and reagent please don't measure other types of analyzer are used, because the control material and reagent in the face of some additives may cause damage to the electrode. 9.13 Problems on Fuse Confirm the fuse has burned out, need to perform following replacement: Turn off the power switch, unplug the power plug; A convex mark in the power supply socket analyzer on the cover using a screwdriver, lever out the fuse socket outward force; Remove the fuse burned out; Install new fuse. 9.14 No flush or flow slowly The flush solution is out: to replace a new reagent pack. Electrode dislocation or not installed by pressing wrench compression, so that measuring the pipeline does not seal: this can be seen when cleaning with a cleaning liquid overflow on the electrode surface. Need to be installed and tightened electrode. Cleaning pump weak or damaged: replace the pump. Cleaning pipeline damaged or blocked: piecewise check syringe, replace the defective pipeline. Cleaning the pump does not turn: required by the electrical technicians to inspect the relevant circuit. 9.15 No Cal A or Cal B Error message "No Cal A" (or "No Cal B"), and returns to sleep. Electrode dislocation or not installed by pressing wrench compression, so that measuring pipeline is not sealed: re electrode installed correctly and fasteners. A suction pump is weak or damaged: replace the pump. The suction pipeline damaged or blocked: piecewise check syringe, replace the defective pipeline. 9.16 No sample when sampling Have a careful check according to the instruction. If the problem can not be settled, please contact Cornley for further guidance. Page 63 9.17 Problems on Pump Tubes In case of any of the following circumstances, it means the pump tube shall be replaced Over the shelf life Pipe sticking together. Pump tube aging. Pipe rupture. 9.18 Loose Connector The power supply interface loosening: analyzer cannot test. Reagent: interface loosening caused interface showed no reagent. As for the above problem needs to check whether the interface loosening, if yes, then connect the interfaces well. Page 64 Chapter 10 Maintenance This section includes the recommended maintenance procedures for the instrument. The frequency of preventive maintenance operations is based on average workload of 20 to 30 samples per day with a normal instrument use. Facilities with heavier workloads should schedule maintenance operations more frequently. Wear disposable gloves to avoid contact with potentially infectious materials while maintaining the instrument. 10.1 Daily maintenance The maintenance operations described here are recommended to be performed everyday just before or after routine measurements. 1. Clean the probe and sample tray 2. Clean surface of the instrument. 3. Do TCO2+ 2 PT calibration first to check the instrument first. After calibration is passed, test a sample to check. 4. Near day off, do deproteinization or cleaning to maintain electrodes and reaction cell if necessary. 10.2 Weekly maintenance The maintenance operations described here are recommended to be performed every week at the end of the routine measurements. 1. Sterilize exterior and interior surface and aspiration probe tie-in 2. Take out reference electrode and shake it for serial time to avoid crystal formation. 3. Cleaning the flow path to prevent blockage. 4. Check the multiplexer if there is any leakage. 5. Check TCO2, Cal A if it is not enough. 6. Test middle level QC, adjust slope and intercept accordingly. 7. Perform deproteinization and cleaning to maintain electrode and reaction cell. 8. Clean flow path with syringe. Hard pushing can break the membrane. Careful cautions should be taken when sterilizing probe to avoid injury and potential infections. Page 65 10.3 Monthly maintenance 1. Check the solution level of K+, Na+, Cl- electrodes. Replace the refill solution of K+, Na+, Clelectrodes if it is less than 2/3. For K+, Na+, Cl-, Ca2+ and pH electrodes, empty the remaining refill solution before filling new. 2. Correct coefficient factors (slope and intercept) with high/middle/low level QC. 3. Take out the reference electrode, remove crystal if there is too much. Refill if the solution is not enough. 4. Clean the entire flow path to avoid blockage 10.4 Yearly Maintenance To do a completed inspection for the instrument every year. 10.5 As necessary 1. Never switch off the analyzer 2. Never mix old and new reagents together 3. Serum must be centrifuged within one hour after the collection of blood sample 4. Do not change the slope or interception frequently. Minor changes are OK for routine checks. 5. No direct strong light on multiplexer. 6. The instrument may be abnormal if the operation or maintenance is not done strictly according to this manual. 7. Only the trained engineer can do maintenance and fix for the instrument. All spare parts for such maintenance and fix must be original from Cornley. 8. If the analyzer must be stopped with any reason, the flow path must be washed and emptied. The calibration standard solutions must be handled according to guidance of 6.9.1. 9. To prevent the clot in flow path, please 1) The liquid level of the serum in the tube must be over 10mm; 2) Please separate the protein fibers from the serum samples. 10.6 Shelf life Storage shelf life:three years Page 66 Designed usage shelf life:five years 10.7 Transportation and storage This analyzer allows the use of common traffic tools. But need to prevent the severe impact, vibration, and rain splash during transportation process. Transportation requirements must be included in the contract. Analyzer packaging should be stored indoors with ambient temperature -20℃~+55℃, relative humidity of not more than 80%, non corrosive gas with good ventilation. For the long-term storages, the analyzer is required to be power-on once a month and dehumidification at the same time. Page 67 Appendix A Symobols IVD product CE mark Biological contamination risk Alert Notice This way up Please consult the manual Serial number of the analyzer Electronics waste Possible injury for hand Warning of high temperature Risk of electric shock Laser EC representative Page 68 Manufacture date Manufacturer Keep away from rain Keep away from sunlight Only three layers at the most Fragile Page 69 Appendix B Barcode scanner initialization If “Barcode error!” appears when scanning the barcode of consumable, please initialize the scanner according to the following steps: 1. Make sure the scanner is well connected to analyzer; 2. Please scanner the barcode as below one by one: Steps Barcodes 1.Code Programming ON 2.Baud Rate:19200 3.Data Bit,No Check,1 Stop Bit 4. Code Programming OFF 3. After initialization, scan the barcode of consumable again. If it does not works,please connect representative. Page 70 Te c hnic al Do c ume nt Auto s ample r CORNLEY Product name Auto sampler Manufacture Meizhou Cornley Hi-Tech Co., Ltd Nanshan Estate Baigong, Meizhou, Guangdong, 514765, China Country of origin China Product Description The Auto sampler is a compact, easy-to-use option for users who value letting their instrument to get on with the analyses. It makes the perfect walk-away system for laboratories with high workload. Just pre-load up to 25 samples and let the Auto sampler do the work. It tilts and reads its barcode. Note that emergency samples can easily be analyzed in the middle of an automated run. Model configuration Figure 1 – Auto sampler Instructions for use Use in accordance with manufacturer’s instructions for use in AFT-800 User´s Manual Storage +5 to +35 ºC Packaging and Weight 347mm x 277mm x 451mm (L x W x H); 6.5 kg, MEIZHOU CORNLEY® HI-TECH CO,.LTD Nanshan Estate Baigong, Meizhou, Guangdong, 514765, China (+86-753) 2878808/(+86-753) 2878811 wwww.cornley.com Instructions for Installation of electrodes According to different functions, the electrodes can be grouped as below: CORNLEY ISE electrodes: K+/Na+/Cl-/Ca2+/pH. Refillable.The K+, Cl-, Ca2+ electrodes need to refilling solution before installation. When solution less height than 1/2, user need to dry the electrode and refill .The refilling solution has to be replaced for every 3 months. Reference electrode: Fixed type with internal solution. The steps to add refilling solution to ISE electrodes: 1) Open the contact terminal of Li+, K+, Na+, Ca2+, pH, Cl- electrode (taking Na+ electrode as the example in the pictures): 2) Empty the internal electrode solution. 3) Step1 Step 2 Cut the bottle of refilling solution with a scissors. Use a syringe to aspirate the liquid. 4) Use the syringe to inject refilling solution into the electrode (The needle of the syringe can never touch the bottom of the electrode. Otherwise the membrane may be broken) 5) Step 3 Step 4 To dry the rest refilling solution on the terminal of electrode by tissue paper. 6) The electrode terminal must be properly tightened. Then seize the electrode to upright position. Please click the bottom of electrode several times with a finger to remove bubbles at the bottom of the inner cavity of the electrode. 7) To dry the rest refilling solution on the electrode by tissue paper again. Step 5 Step 7 The steps to add refilling solution to Ref electrode: a) Spin out the cap and terminal of Ref electrode b) Open the small bottle of refilling solution for Ref electrode. Use a sucker or a syringe to aspirate the liquid. c) After the smaller inner cavity of the Ref electrode is filled with refilling solution to the inner cavity mouth, please tighten the electrode terminal of this side first. Then added some more refilling solution to 4/5 of the inner cavity of the bigger side and tighten the electrode terminal of this side. d) Seize the electrode to upright position. Please click the bottom of electrode several times with a finger to remove bubbles at the bottom of the inner cavity of the electrode. e) The refilling solution for Ref electrode is an oversaturated solution. There will be white crystal inside the inner cavity of the electrode during the usage. The refilling solution may volatilize after long time usage. So please add refilling solution for Ref electrode one time. (When replace refilling solutions for ISE electrodes, the original liquid inside the electrodes must be empty first. However, it is OK to add refilling solution for Ref electrode directly no matter the electrode is empty or not. Please notice that the refilling solutions for ISE electrodes and Ref electrodes are different. Please only add correct refilling solution to the correct electrode(s).) 8) After inject enough refilling solution into the electrodes, please install them into the measuring chamber according to the order (from left to right) of Li+, K+, Na+, Ca2+, Cl-, pH and Ref. Installation steps: 1. Open the front cover of the analyzer and the cover of measuring chamber. 2. For the first usage of all electrodes, or the refilling solution in one electrode is less than half of its inner cavity, new refilling solution must be injected into the electrode(s). 3. Before installation, please use a clean paper towel to clean the measuring chamber and the electrode terminal. 4. Pull the spanner to right 5. Check whether the O-rings on the both sides of each electrode are normal or not. Use a tissue paper to clean the channel of each electrode. 6. Place the electrode head tightly against spring. Then press to inner side and trim all electrodes from left to right according to the correct order. 7. Install the Ref electrode at last. 8. Level all electrodes again when all of them are installed into the right places. 9. Release the hand slowly so that the spanner can press all electrodes tightly. 10. Check whether all electrodes are leveled or not at last. 11. Close the cover of the measuring chamber. Electrodes shall maintain a channel end to end to form of a Flow path (no dislocation) After installation, please check whether there is any bubble at the bottom of every electrode. If yes, please tap the bottom of the electrode several times to remove the bubble. Correct position of each electrode is shown in the picture below.